Regulatory Information

Navigate the Regulatory Information Section

Legislation

The Federal Food, Drug, and Cosmetic Act and other congressional milestones are presented in this section.

Rules & Regulations

Rules and regulations help FDA ensure that regulated products are safe and effective.

Search for FDA Guidance Documents

Search for official FDA guidance documents and other regulatory guidance for all topics

Dockets Management

Dockets management serves as the official repository for the administrative proceedings and rule-making documents for FDA

Freedom of Information

Electronic reading rooms contain publicly releasable agency records and other information routinely made available.

Standards

FDA participates in the development of standards and uses standards to fulfill its regulatory responsibilities.

Recently Posted Guidance Documents

Page Last Updated: 02/25/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.